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The webinar targets executives and staff in quality control laboratories and quality assurance, who want to get an overview on GMP requirements with respect to stability and expiry dating of reagents, solvents, standard and sample preparations, as well as their efficient practical implementation.
Objectives
According to EU GMP Guide Part 1, Chapter 6, Quality Control and US 21 CFR 211.160, analytical procedures must be designed to ensure that drug products meet the quality standards and the specifications with respect to strength and purity defined in the marketing authorisation. This includes a suitable control of analytical procedure components such as reagents, solvents, standard and sample preparations to ensure an accurate and reliable analytical result. Thus, the shelf-life and storage conditions of standard and sample solutions should be demonstrated, as discussed in the USP General Information Chapter <1226>“Verification of compendial procedures“.
Programme
Besides regulatory expectations, the Shortcut provides recommendations with respect to stability investigations of test solutions for qualitative and quantitative use. Suitable stability study designs, data calculations and assessments will be presented, in order to achieve a reliable and traceable shelf-life Determination.
The following topics will be covered:
Requirements to solutions for qualitative and quantitative use
Correspondig addition to USP General Information Chapter <1226> “Verification of compendial procedures“ (valid December 1, 2019)
What changes are acceptable for qualitative and quantitative use?
Appropriate evaluation of stability results. Why is the assessment of individual results not suitable?
Evaluation of stability data by averaging and regression
Determination of the shelf-life of standard and sample solutions
Further Information
The purchase process for the GMP & GDP Shortcuts is handled via the sales platform Digistore24 ( www.digistore24.com). Please understand that it is not possible to place an order on account in this case. By clicking the “Book now” button at the top right, you will be redirected to Digistore24.
After successful payment, you will automatically receive a confirmation email from Digistore24 and an email from Memberspot (our streaming provider) asking you to register. Afterwards, you will have access to the purchased video for 7 days.
Please note: The booking is valid only for the registered participants. The use by other persons is prohibited and constitutes an infringement of copyright.
Presentation and certificate: Starting from the purchase date, the presentation will be available for you to download in Memberspot for 7 days. Afterwards, the participants can download a certificate of attendance.
Please note: When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
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